Integrating Practice with Precision: A Quantitative HER2 Protein Assay Developed for Clinical Application in Trastuzumab Deruxtecan Treatment Guidance - Summary - MDSpire

Integrating Practice with Precision: A Quantitative HER2 Protein Assay Developed for Clinical Application in Trastuzumab Deruxtecan Treatment Guidance

  • By

  • Junmei Hao

  • Xiaochun Fei

  • Fangfang Zou

  • Qian Hu

  • Linlin Du

  • Liya Yu

  • Xuanye Bai

  • Shasha Bi

  • Qinghua Cao

  • Weishan Chen

  • Qun Dai

  • Tingting Guo

  • Hai Huang

  • Wenwei Jiang

  • Baohua Li

  • Lixia Li

  • Jingjing Liu

  • Tong Liu

  • Xiaoqin Liu

  • Jiahong Lyu

  • Yue Pan

  • Xiaoqing Shao

  • Fangrong Tang

  • Tingting Wang

  • Cuiping Zhang

  • Yongcun Zhu

  • Job Tien Chiang Liu

  • Nicole Salazar

  • Shukun Zhang

  • Jiandi Zhang

  • Xiaosong Chen

  • Chaofu Wang

  • April 27, 2026

  • 0 min

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Objective:

To explore a quantitative HER2 assay based on the Quantitative Dot Blot (QDB) method to improve the accuracy of HER2 assessment for guiding Trastuzumab Deruxtecan (T-DXd) treatment, addressing the limitations of current IHC methods.

Key Findings:
  • QDB showed higher consistency than IHC with an ICC of 0.877 vs. 0.513, indicating significant improvement in reliability.
  • ROC analysis yielded an AUC of 0.9477, indicating strong predictive capability for distinguishing HER2 levels.
  • A cutoff of 0.2746 nmole/g was established to stratify specimens, achieving overall concordance rates of 90.9% and 92.0% in training and validation cohorts, respectively, highlighting the assay's effectiveness.
  • Approximately 15% of specimens classified as IHC 0 were identified as 1+ by QDB, suggesting the assay's potential to reclassify patients for better treatment options.
Interpretation:

The QDB HER2 assay provides a more reliable quantitative assessment of HER2 levels, particularly in distinguishing between HER2-low and HER2-0 patients, which is critical for optimizing T-DXd treatment and improving patient outcomes.

Limitations:
  • The study is retrospective and relies on previously archived specimens, which may introduce selection bias.
  • The sample size, while adequate, may limit the generalizability of findings to broader populations.
Conclusion:

The QDB HER2 assay is a promising alternative for guiding T-DXd treatment by accurately distinguishing HER2-low from HER2-0, paving the way for improved patient stratification and personalized therapy.

Original Source(s)

Integrating Practice with Precision: A Quantitative HER2 Protein Assay Developed for Clinical Application in Trastuzumab Deruxtecan Treatment Guidance

  • by Junmei Hao, Xiaochun Fei, Fangfang Zou, Qian Hu, Linlin Du, Liya Yu, Xuanye Bai, Shasha Bi, Qinghua Cao, Weishan Chen, Qun Dai, Tingting Guo, Hai Huang, Wenwei Jiang, Baohua Li, Lixia Li, Jingjing Liu, Tong Liu, Xiaoqin Liu, Jiahong Lyu, Yue Pan, Xiaoqing Shao, Fangrong Tang, Tingting Wang, Cuiping Zhang, Yongcun Zhu, Job Tien Chiang Liu, Nicole Salazar, Shukun Zhang, Jiandi Zhang, Xiaosong Chen, Chaofu Wang

  • April 27, 2026

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